Set Sail for Efficiency: How LIMS Addresses the Challenges of IS0 17025
To discuss how LIMS can turn challenges into chances, it is necessary to take a closer look at several key ISO 17025 sections — specifically the “Management Requirements” and “Technical Requirements”.
- 4.1 Organization and Management: Labs must not only meet standards within their own facilities, they are responsible for compliance at third-party facilities and temporary facilities – such as field-based labs – as well. This not only strengthens compliance, but also it establishes a quality benchmark to which all laboratory practices and data must conform. To manage this level of complexity without disrupting daily activity, a LIMS must use a web services architecture that is both secure and extensible. Proper security controls are especially important for external laboratories – and those doing business with them – because proprietary, confidential data is continuously stored and accessible. A proven LIMS will address this by providing “group security,” which limits access to specific projects or clients, and by providing native browser encryption (SSL) for web access.
- 4.2 Quality System: Quality and consistency are merely concepts unless policies, systems and programs are documented and reinforced. ISO 17025 not only calls for documentation of quality systems and procedures, it requires that it “be communicated to, understood by, available to and implemented by” appropriate personnel. The LIMS system can be the conduit for quality system documentation and reinforcement. Not only can relevant quality information be stored within the LIMS — or easily accessible via an intranet — but labs can also insert hyperlinks on landing pages and dashboards within the LIMS as just-in-time reminders to staff of quality system requirements.
- 4.3 Document Control: Document control is an important component of a quality system. All documents generated internally or externally must be indexed and available on-demand. This includes any document type, including drawings, manuals and methods. A LIMS can store relevant documents in nearly any standard format as an attachment, making compliance with document control a natural extension of routine laboratory work.
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